Devices, systems, and methods for delivering fluid to tissue

ABSTRACT

A needleless fluid injection device including a flexible shaft with a proximal end, a distal end, an injection lumen extending from the proximal end to the distal end of the shaft, and at least one injection orifice extending through a wall of the injection lumen at the distal end of the shaft. The injection lumen can include a depth-limiting system ( 462 ) at its distal end for controlling the depth of insertion of the injection lumen relative to a target tissue of a patient. The injection lumen can alternatively or additionally include at least one guidance feature. The injection lumen can alternatively or additionally include at least one flow-modifying protrusion extending from the inner tubular wall of the injection lumen and toward a longitudinal axis of the injection lumen.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation application of U.S. patentapplication Ser. No. 14/153,709, filed Jan. 13, 2014, which is adivisional application of U.S. patent application Ser. No. 13/260,869,filed Nov. 18, 2011, now U.S. Pat. No. 8,628,494, which claims thebenefit from International Application No. PCT/US2010/042591, filed Jul.20, 2010, which in turn claims priority under 35 U.S.C. §119(e) to U.S.Provisional Application No. 61/226,805, filed Jul. 20, 2009, titled,“High-Pressure Flow Distribution Injection System and Method”; U.S.Provisional Application No. 61/226,832, filed Jul. 20, 2009, titled,“High-Pressure Injection System and Method”; U.S. ProvisionalApplication No. 61/226,849, filed Jul. 20, 2009, titled, “Depth LimitingHigh-Pressure Injection System and Method”; U.S. Provisional ApplicationNo. 61/226,855, filed Jul. 20, 2009, titled, “High-Pressure PolymerInjection System and Method”; and U.S. Provisional Application No.61/226,796, filed Jul. 20, 2009, titled, “Injection Catheter andGuidance System and Method”, the entire contents of which are allincorporated herein by reference in their entireties.

TECHNICAL FIELD

The present invention relates generally to the delivery of therapeuticfluids to a treatment site within a patient. More specifically, theinvention relates to methods and devices for treating tissue within thehuman body using a pressurized injection system that accurately deliverstherapeutic fluids to a desired location, such as the urinary tract of apatient.

BACKGROUND

A wide variety of medical treatments utilize the delivery andintroduction of therapeutic compositions to a treatment location in apatient. In home or outpatient settings, the delivery methods used caninclude procedures such as oral delivery or inhalants, while in clinicalor hospital types of settings, a therapeutic fluid is often injectedusing a needle-based system. In more complicated methods, a fluid can bedelivered surgically through a tubular device, such as a catheter orendoscope, and in some cases, the surgical method can involve minimallyinvasive procedures.

For minimally invasive procedures, a number of systems have beendeveloped for delivering therapeutic fluids to treatment sites within apatient that include minimally invasive, tubular delivery lumens (e.g.,catheters or endoscopes) and pressurized fluid sources. In some cases,these fluid sources include a syringe-like structure that is actuated bya plunger. This plunger can be controlled via a console having controlfeatures that help the user to control the amount of pressurized fluidthat is delivered to and/or expelled from the system. These systems caninclude needleless fluid injection systems, for example. Needlelessdevices and methods for treating tissue of the urinary tract arediscussed, for example, in U.S. Patent Application Publication No.2009/0312696 (Copa et al.), and U.S. Patent Application Publication No.2006/0129125 (Copa et al.), the entire disclosures of which areincorporated herein by reference. One particular application forneedleless fluid delivery systems is for treatment of diseases of theprostate, such as prostatitis, benign prostatic hyperplasia, andprostatic carcinoma.

Needleless fluid delivery systems can include the use of a tube-likedevice, such as an elongated catheter tube, which is configured toprovide a jet-injection of a therapeutic fluid at a desired treatmentsite. Generally, a needleless injector is used to deliver thetherapeutic fluid that is provided from an external reservoir that islocated at a proximal end of the tube-like device. The actual fluidadministration occurs at a distal end of the tube-like device. Due tothe relatively long travel length of the therapeutic fluid through thetube-like device, an injector must generally be capable of pressurizingthe therapeutic fluid to a relatively high pressure in order to achievea certain desired fluid delivery pressure at the distal end of thedevice.

For any injection or injected tissue, therapeutic agents are desirablydelivered with minimal discomfort and procedure time, and with the bestpossible degree of accuracy of delivery location and delivery volume,and with uniform and accurate distribution of a fluid throughoutinjected tissue. Further, due to the characteristics associated with thedelivery of therapeutic compositions to treatment locations in apatient, there is a need to provide improved procedures, systems, andcomponents for fluid delivery using needleless fluid delivery systems.Such procedures, systems, and components can provide for accurate andcontrolled dispensing of therapeutic compositions to specific treatmentlocations within a patient. In particular, there exists a continuingneed to provide improved devices for delivering therapeutic fluids todifferent tissues such as locations of the urinary tract including thebladder, bladder neck, prostate, urethra, kidneys, and ureters.

SUMMARY

The invention generally involves needleless fluid injection devices,systems, and methods. These devices and systems allow for targeteddelivery of therapeutic fluids at desired anatomical tissue locations,such as locations in the male or female urinary tract. The therapeuticfluids can include biologically active species and agents such aschemical and biochemical agents, for example. Exemplary devices aredesigned to deliver fluid at various tissue locations, and can furtherdeliver multiple different therapeutic fluids having varying materialproperties (e.g., viscosity) using a single system. The devices can becapable of delivering precise amounts of fluid for injection at preciselocations and at specific pressures to a location in the patient.

Embodiments of the described invention involve a fluid delivery systemwith an injector source and an access device. The access device cancomprise a minimally invasive, tubular delivery lumen such as a catheteror endoscope. The injector source can include a non-metal, polymerictube-like device for delivering a therapeutic fluid to a treatment sitewithin a patient. The tube-like device can further include one or moreapposing jets that can be selectively fired to force the injectionorifice or orifices of the tube-like device against the target tissue.Selective firing can include a continuous firing during the injection toimprove the efficiency of the treatment. The apposing jets can includenozzles or vanes to improve the ability of the operator to selectivelyfire the apposing jet for creating contact with the target tissue.

In various embodiments, devices as described can be useful for injectingtissue at different tissue depths and in any desired direction (relativeto a surface of the injected tissue), including relatively deepinjection of fluid into tissue of any size or depth, or for shallowinjection of fluid into tissue at a depth near a tissue surface, such asif the tissue is of a limited depth. Depending on the desired injectiondepth, orifices can be oriented at different locations along a length ofa shaft and at different directions or angles relative to the shaft.

Certain devices as described provide features for handling, placement,control, and accuracy of injected fluid in terms of locationdistribution, and volume of fluid delivery. For example, multipleinjection orifices can be arranged along a length or a circumference ofa shaft to cause forces produced by ejection of fluid to be balanced orotherwise controlled, relative to the shaft. In some embodiments, a netforce on the shaft created by the ejection of fluid from multipleorifices at a shaft distal end can be zero. In other embodiments, a netforce on a shaft created by the ejection of fluid from multiple orificesmay create a force used to control the distal end of a device. A netforce may be created by ejected fluid, for example, to place aninjection orifice in apposition to tissue. That is, a net force cancause a shaft and an injection orifice to be pressed against a tissuesurface to provide for secure engagement between the injection orifice,shaft, and tissue surface during a fluid delivery process.

In one aspect of this invention, a needleless injection device isprovided that includes a flexible catheter shaft comprising a proximalend, a distal end, a distal end tip, and an injection lumen extendingfrom the proximal end to the distal end. The distal end includesmultiple injection orifices that are spaced from each other along thelength and/or circumference of the injection lumen and which are incommunication with the injection lumen. The shaft is capable of ejectinga fluid stream from each of the injection orifices, wherein the fluidstreams are capable of being injected into tissue by penetration of atissue surface as a fluid stream. The injection lumen further caninclude one or more features that are positioned within its interiorarea that can alter the flow of fluid, thereby providing for certainoutflow characteristics. In particular, the features can be formed orshaped to include one or more interior flow features or protrusions thatgenerally restrict and/or redirect the fluid flow through the lumen toprovide for controllable distribution of flow through each of theorifices. For example, these flow features can be used to achievecertain flow rates through particular orifices, or may be used to makethe flow rate relatively uniform for fluid exiting all of the orificesof one lumen.

In another aspect of the invention, an injection device and system canbe configured without means for connecting or attaching an optic device,such as an endoscope, to an injection catheter, while still being ableto utilize the other component features of the system, such as adelivery lumen, fluid source, apposition device, and the like. A systemof this type can advantageously include additional torque controlmechanisms that may be relatively difficult to incorporate or use if thesystem includes an optic device and its corresponding structure. Thetorque structures used can include a braided tube, coils, micro-machinedtubes, kink-resistant tubing (KRT) features, and the like, and can bemade of a number of different materials, such as metals, polymers, andceramics.

In another aspect of the invention, a delivery lumen can includedepth-limiting or depth-controlling features that can be attached orotherwise incorporated into the device. These features can help tocontrol or limit the indentation of the distal end tip of the devicewhen positioning the injectate ports or orifices in a desired positionto promote transverse or radial injectate dispersion from the ports.This can be accomplished via an expandable and collapsible member, suchas a hinging or folding plate member. The member or members can bemanually or automatically deployable, such as with an actuation memberthat controls the expansion and/or retraction. Alternatively, themembers can be constructed of a shape memory or biased material thaturge the members into either an open or closed position. These memberscan be expandable to abut with the surrounding tissue walls of the lumeninto which the device is positioned. The members may comprise variousstructures, mechanisms, and techniques, such as hinged members, biasingmembers, pop-out members, inflatable members, and the like.

In accordance with the invention, a delivery lumen and its associatedcomponents can be constructed of specific polymer materials havingreinforcement features. The reinforcement can be incorporated or mixedinto the polymer material or can be provided as a coating. The materialscan provide additional strength to the lumen that will allow it tobetter withstand the pressures used with these relatively high-pressureinjection catheters.

In another aspect of the invention, a device can be provided withvarious guidance or targeting features that can be coupled with othervisualization systems (e.g., optics or an endoscope). In one particularembodiment, the injection catheter or lumen can include at least onesurface indicia or marker and/or at least one protrusion that isdetectable using ultrasonics, x-rays, and the like.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be further explained with reference to theappended Figures, wherein like structure is referred to by like numeralsthroughout the several views, and wherein:

FIG. 1 is a schematic illustration of one embodiment of a needlelessfluid delivery system for delivering a therapeutic fluid to a treatmentlocation, in accordance with the invention;

FIG. 2 is a schematic illustration of another embodiment of a needlelessfluid delivery system and optical system, in accordance with theinvention;

FIG. 3 is a schematic illustration of a needleless fluid delivery systemthat does not include an integrated or attached optic system;

FIG. 4 is a perspective view of an embodiment of a distal end portion ofa delivery catheter or lumen and including a protruding guidance ortargeting feature;

FIG. 5 is a perspective view of another embodiment of a distal endportion of a delivery catheter or lumen including a surface indicia ormarker;

FIG. 6 is a front view of an indicator band located proximate to aninjection port of an injection lumen of a fluid delivery system of theinvention;

FIG. 7 is a rear view of the portion of a fluid delivery systemillustrated in FIG. 6;

FIGS. 8 and 9 are schematic front views of a distal end of a fluiddelivery system including a depth-controlling feature in its open andclosed positions, respectively;

FIG. 10 is a schematic cross-sectional front view of a distal endportion of a fluid delivery lumen illustrating relatively non-uniformfluid flow through its orifices; and

FIGS. 11-13 are schematic cross-sectional front views of distal endportions of fluid delivery lumens of the invention, illustrating variousflow disruption injection systems for controlling and varying fluid flowthrough their orifices.

DETAILED DESCRIPTION

The invention relates to devices and methods useful for injecting fluidinto tissue for treatment. The fluid can be injected without the use ofa needle and can therefore be referred to as a “needleless” fluidinjection system. Needleless fluid injection systems of the inventioncan include one or more orifices that deliver fluid in the form of a jetor fluid stream without a needle passing into the tissue. This fluid isdelivered at a pressure, velocity, and stream size that allow the fluidstream to pass through a tissue surface, penetrate into the bulk of thetissue below the tissue surface, and become dispersed as fluid particleswithin the tissue, such as in the form of a cloud of dispersed fluidparticles or droplets. The type of tissue injected for treatment can beany amenable tissue, such as tissue at or near the urinary tract (e.g.,tissue of the prostate, kidneys, ureters, urethral tissue, bladder, orother tissues such as heart tissue).

Needleless devices of the type described herein generally include adistal end and a proximal end. As used herein, a “distal end” of adevice or system refers to an end area or portion of the device orsystem that can be introduced within a patient's body during a treatmentprocedure. For example, elongate shafts or catheters of the needlelessinjection systems of the invention generally include a distal end thatis the first portion of the device that is inserted into the patient fortreatment. The distal end may include functional features that operateon fluid or tissue during use, such as one or more orifices, deliveryheads (e.g., end effectors, nozzles, etc.) that house one or moreorifices, a frictional tissue holding tip, tissue tensioners, lightingor other optical features, steering features, and the like.

As used herein, a “proximal end” of an exemplary needleless device orsystem is the end that is generally opposite the distal end of thatdevice or system. It is noted that each individual component of a systemcan include its own proximal and distal ends, while the overall systemcan also include proximal and distal ends. For one example, a needlelessfluid injection system of the invention can include an injector body orconsole at a proximal end that remains external to the patient duringuse and an elongate shaft or catheter tube at a distal end. One or moreinjection orifices at the distal end can be in fluid communication withthe console.

An exemplary console used with systems of the invention can include ahousing that connects to or is otherwise (directly or indirectly) influid communication with an elongate shaft or catheter tube. The consolecan include fluid that can be pressurized by a pressure source to causethe fluid to flow through the shaft for injection into tissue at thedistal end. A device can eject fluid from one or multiple ejectionorifices that can be located at the distal end of the shaft or cathetertube.

The fluids that are injected into tissue using systems of the inventionmay be referred to as an “injectate” or “injection fluid”, which may beany type of fluid such as a therapeutic fluid. A fluid stream or jet ofinjectate can be of a size (e.g., diameter), velocity, pressure, andvolume to allow the fluid stream to penetrate directly through a tissuesurface, then disperse within the tissue. The stream can be consideredto be a relatively high velocity, high pressure, small diameter jet thatafter entry through a tissue surface, disperses within the tissue,preferably as a multi-directional collection of particles (e.g., a“cloud”) or droplets within the bulk of the tissue. Exemplary pressuresof a fluid at a pressure chamber can be at least 200 pounds per squareinch (psi), and in some embodiments can range from 300 to 5000 poundsper square inch.

Referring now, to the Figures, wherein the components are labeled withlike numerals throughout the several Figures, and initially to FIG. 1,one exemplary configuration of a needleless fluid delivery system 100 isschematically illustrated. Delivery system 100 generally includes aninjection console 102, an injection chamber 108 in operativecommunication with the console 102, and a catheter tube or injectateshaft 104 that is also in operative communication with the console 102.The console 102 includes a user interface 106, which can be used foractivating and controlling the activities of the various components ofthe delivery system 100. The user interface 106 can include an inputmeans for selectively delivering a volume of pressurized fluid throughthe injection chamber 108. The user interface 106 may further includeone or more actuatable devices, such as a foot petal, a hand activatedcontroller, switches, buttons, and/or the like. It is also contemplatedthat the user interface 106 can include a touch-screen that is capableof receiving touch commands and may optionally include a display systemfor displaying information such as the mode of operation that is beingused and/or certain operating parameters of the system.

Although console 102 can include a wide variety of features, any consoleused in the fluid delivery systems of the invention can generallyinclude a housing, a pressure chamber, and a pressure source. A consolecan have any configuration, size, or design, ranging from a small,hand-held design to a relatively large floor or table-mounted console.The consoles can also include separate or separable components such as apressure chamber or injection chamber that can be attached, used for aninjection procedure, and detached and then optionally discarded orsterilized and reused. A shaft or catheter tube can also be attached toa console or a pressure chamber in a manner that facilitates separationand optional re-attachment or disposal.

With separable components, the injection chamber can be attached to aconsole housing and used to inject a first patient and/or a firstinjectate, and then the shaft or pressure chamber can be removed anddiscarded or sterilized. A second shaft or pressure chamber can then beattached to the console to treat a second patient or the first patientwith second injectate or administer another treatment of the firstinjectate. The second patient or injectate can involve injection andtreatment of the same type of tissue as the first patient or injectate,or of a new type of tissue than was treated in the first treatment. Inthis manner, separable and optionally disposable shaft or pressurechamber components of a needleless injection system can allow a consolehousing to be used multiple times to inject the same or differentinjectates to the same or different patients, and to the same ordifferent types of body tissue, thereby providing an injection systemthat is flexible for use in a wide variety of situations and with a widevariety of fluids. Examples of system configurations, features andcombinations of system features that can be useful according to thepresent description include U.S. Patent Application Publication No.2006/0129125 (Copa et al.); U.S. Publication No. 2009/0312696, filedJun. 27, 2008 (Copa et al.); PCT patent application Serial No.US09/06390, filed Dec. 4, 2009 (Crank et al.), titled “Devices, Systems,and Related Methods for Delivery of Fluid to Tissue”; PCT patentapplication Serial No. US09/06384, filed Dec. 4, 2009 (Crank), titled“Needleless Injection Device Components, Systems, and Methods”; PCTpatent application Serial No. US09/06383, filed Dec. 4, 2009 (Rykhus etal.), titled “Method and Apparatus for Compensating for Injection MediaViscosity in a Pressurized Drug Injection System”, the entireties ofwhich are all incorporated herein by reference.

The console can include actuating features to control distal endfeatures of the system, such as steering a steerable distal end of asteerable shaft, actuating ejection of fluid, moving a moveable orextendable injectate shaft or one or more injection orifices relative toanother shaft component such as a working shaft, and may further includeoptional ports to connect a console housing to auxiliary devices,electronics such as controls, optic features such as a lens, fiberoptic, or electronic viewing mechanism to allow viewing through anoptical feature (to view a location of delivery), and an actuatingmechanism or pressure source for a tissue tensioner in the form of amechanical tissue tensioner or an inflatable balloon. One or moreattachment ports can optionally attach a console to an external andoptionally remote component such as an external or remote pressuresource, vacuum source, or an external or remote fluid reservoir tosupply injectate or other fluid, such as to inflate a balloon.Embodiments of consoles can include a permanent or removable pressurechamber and a pressure source capable of pressurizing a fluid containedin the pressure chamber to cause the fluid to flow from the console,through a lumen in the shaft, and then through an injection orifice.

Examples of consoles, console features and combinations of consolefeatures that can be useful according to the present description areidentified in Applicants' copending U.S. Patent Application PublicationNo. 2006/0129125; U.S. Publication No. 2009/0312696, filed Jun. 27, 2008(Copa et al.); PCT patent application Serial No US09/06383, filed Dec.4, 2009 (Rykhus et al.), titled “Method and Apparatus for Compensatingfor Injection Media Viscosity in a Pressurized Drug Injection System”;and PCT patent application Serial No. US09/06381, filed Dec. 4, 2009(Crank), titled, “Devices, Systems and Methods for Delivering Fluid toTissue”, the entire disclosures of which are incorporated herein byreference.

Fluid can be provided to the system 100 by a fluid supply 110, which canbe provided as a syringe that is manually activated, such as byphysically pressing a plunger into a syringe barrel that is at leastpartially filled with fluid to push fluid from the syringe barrel.Alternatively, fluid supply 110 can have a different configuration thana syringe, and the fluid supply can be automatically or mechanicallyactivated, such as with an electronic fluid supply controller and/orwith one or more remote activation devices that can be manipulated bythe user to move the plunger into and out of a syringe barrel. In yetanother alternative, the fluid supply 110 is not a syringe, but insteadincludes a larger fluid source, such as a reservoir or other containerthat holds the fluid until it is provided to the injection chamber 108.Such a container can be positioned so that the fluid is gravity fed tothe injection chamber, for example, or so that the fluid can beextracted using a vacuum source, for another example. With any of thedifferent types of fluid supplies used with the systems of theinvention, it is contemplated that an exact amount of fluid to beadministered can be premeasured and provided to the system until thatquantity of fluid is depleted and/or a predetermined amount of fluid canbe extracted from a relatively large fluid supply.

A pressure chamber or injection chamber, such as injection chamber 108,can be a type of fluid chamber for containing one or more fluids (e.g.,control fluid or injectate) for a purpose of placing the fluid underpressure to deliver the fluid through a lumen to a distal end of a shaftfor ejection from an ejection orifice. Examples of pressure chambersinclude a syringe chamber and other variable volume spaces that can beused to contain and pressurize a fluid. Examples of variable volumepressure chambers include spaces that can exhibit a variable volume forincreasing or decreasing the volume (and correspondingly decreasing orincreasing pressure) within the variable volume chamber space. Suchpressure chambers can include a plunger, piston, bellows, or othermechanisms. A pressure chamber can be pressurized by a pressure sourceattached to the plunger, bellows, or piston, etc., such that fluidcontained in the pressure chamber is ejected under pressure. Thispressurized fluid can be used for priming a device and/or for ejectingfluid from an ejection orifice for injection and/or to produce a controlforce, for example. A pressure source may be any source of energy (e.g.,mechanical, electrical, hydraulically derived, pneumatically derived, orthe like) such as a spring, solenoid, compressed air, manual syringe,electric power, hydraulic, pneumatic pressure sources, or the like. Apressure chamber may be a permanent or removable (i.e., attachable anddetachable) component of a console housing.

In communication with a proximal end of the devices of the invention isan elongate shaft, which may also be referred to as an “injectateshaft.” The injectate shaft extends from its proximal end, which isoptionally removably connected to the console (or a component of theconsole such as a removable pressure chamber), to its distal end thatcan be placed in a patient during an injection procedure. The injectateshaft can be of various designs, minimally including an injection lumento carry injectate from a proximal end of the injectate shaft to adistal end of the injectate shaft. Shafts for needleless devices asdescribed are also described in PCT patent application Serial No.US09/06390, filed Dec. 4, 2009 (Crank et al.), titled “Devices, Systems,and Related Methods for Delivery of Fluid to Tissue”; and in PCT patentapplication Serial No. US09/06384, filed Dec. 4, 2009 (Crank), titled“Needleless Injection Device Components, Systems, and Methods”; theentireties of which are both incorporated herein by reference.

The injectate shaft can include structure such as sidewalls that definean injection lumen, the sidewalls being of sufficient strength towithstand operating pressures that are used to deliver injectate fromthe injection orifice at an elevated pressure that causes the injectateto be ejected from the injection orifice to penetrate a tissue surfaceand become injected into and dispersed below the tissue surface. Aninjectate shaft may therefore be made of a flexible material (e.g., ametal or polymeric tube) that can withstand such injection pressure, andmay be prepared from materials capable of withstanding the pressure ofan injection (e.g., nitinol, stainless steel, a non-reinforced polymer,or a reinforced (e.g., braided) polymer). The injectate shaft may befabricated using suitable high strength polymers including, for example,polyimide, polyetherimide available from General Electric under thetrade name “Ultem”, and linear aromatic polymers for transporting thetreatment fluid and the apposing jet medium to the treatment area. Insome embodiments, the injectate shaft can be reinforced through theinclusion of materials including nano-particles, clays and/or glass. Insome presently contemplated embodiments, the injectate shaft can bereinforced with one or more polymers such as, for example, tubes braidedwith Kevlar or other high-strength polymers. The injectate shaft can befabricated so as to have a burst strength exceeding at least about 2,000psi, for example. The non-metal, polymeric tube-like device can befabricated so as to have distention properties, wherein one or moreorifices or jet ports located at a distal end of the polymeric tube-likedevice retains its shape and/or size without suffering swelling that canhave a detrimental impact on a fluid jet used to deliver the therapeuticfluid at the treatment site.

Embodiments of the injectate shaft, such as injectate shaft 104, can beconstructed of specific polymer materials having reinforcement materialstherein or therealong. Other components of the delivery systems of theinvention may also be made of materials that are specifically providedwith reinforcement materials that are either imbedded into thecomponents themselves or otherwise attached to those components. Thereinforcement materials can be incorporated or mixed into the polymermaterial, or provided as a coating. The polymer materials can includepoly ether ether ketone (PEEK), poly ether imide (PEI), poly sulfone(PS), poly ether sulfone (PES), poly ether ether sulfone (PEES), polyphenylene oxide (PPO), poly pheylene sulfide (PPS), poly ketone (PK),poly amide imide (PAT), for several examples. Such a materialcomposition for the injectate shaft, or other components of the deliverysystem, can provide beneficial strength attributes to withstand theinherent pressures experienced in deploying a high-pressure injectioncatheter. In one embodiment, at least a portion of the injectate shaftcan be made entirely of one or more of the above-listed materials.

An exemplary injectate shaft can include a sidewall that defines anouter shaft surface and an inner injector lumen, these being ofcontinuous and relatively uniform dimensions of inner diameter, outerdiameter, and wall thickness, along an entire length of the injectateshaft. Alternately, an injectate shaft, injector lumen, or sidewall, maychange dimensions (e.g., wall thickness) along the length of theinjectate shaft, with a larger wall thickness (e.g., greater outerdiameter) at a proximal end and a thinner wall thickness (e.g., reducedouter diameter) at the distal end. A length of an injectate shaft can beany length that functions to place a proximal end at a console and adistal end at a desired tissue location.

The needleless injection systems of the invention may further includeadditional elongate shaft structures with desired functionality, asingle example being a device referred to herein as “medical deviceshaft” or a “working shaft,” which can be used to securely or moveablysupport or house an injectate shaft. For instance, an injectate shaftcan be incorporated permanently or movably against or within a workingshaft. In exemplary embodiments an injectate shaft can be looselycontained in a working lumen of a working shaft to allow movement of theinjectate shaft length-wise and rotationally relative to the workingshaft. Further, an injectate shaft may be capable of movinglongitudinally within a working lumen to allow the injection lumen to beextended distally from an open end of a working lumen at a distal end ofthe working shaft. The working shaft can be used to manipulate and placethe injection orifice of an injectate shaft at a desired location fortreatment of tissue and can include any of a variety of optionalfunctionalities such as steerability, an optical function, a tissuetensioner, or combinations of these, in addition to supporting theinjectate shaft. An example of a particularly preferred working shaftcan include features of a typical cystoscope, endoscope, ureteroscope,choledoscope, hysteroscope, catheter (e.g., urinary catheter), or thelike, or other similar type of medical device shaft, including one ormore features of flexibility, an optical function, a steerable distalshaft end, and a working lumen.

As discussed above, a distal end of an injectate shaft includes one ormultiple injection orifices for ejecting fluid within a body of apatient. An injection orifice can be any form of opening, aperture, ororifice, such as an aperture or bore in an injectate shaft sidewall, oran aperture or bore in a nozzle, end effector, injection head, or otherstructure in communication with an injection lumen. Injection orificescan be located at relative locations and orientations along a length orcircumference of an injectate shaft distal end to result in ejection anddistribution of ejected fluid in different directions (e.g.,circumferentially relative to the shaft), optionally or alternately atdifferent distances along the length of the injectate shaft. Aninjection orifice can be directed at any angle relative to alongitudinal axis of a shaft, such as perpendicular, angled toward adistal end, or angled toward a proximal end.

According to exemplary injection methods and devices, an injectionorifice may be located on a proximal side of a distal end tip at alocation that allows the injection orifice and adjacent injectate shaftsidewall to contact a tissue surface as a longitudinal axis of a shaftthat contains the injection orifice is positioned in an orientation thatis parallel to the tissue surface. These device embodiments can bereferred to as “side-fire” devices, for example. In certain embodimentsof “side-fire” devices an injection orifice can be located a distanceaway from a distal end tip on a proximal side of the distal end tip sothe injection orifice is located to contact tissue for injection byplacing the shaft sidewall in contact with tissue.

Any high-pressure fluid delivery systems of that are used for needlelessfluid delivery can further include guidance or targeting features thatcan be coupled with one or more corresponding visualization systems,such as an optic system, an endoscope, or another visualization systemthat can detect or otherwise locate the guidance or targeting features.Examples of injection catheters including these features are illustratedin FIGS. 4-7.

FIG. 4 illustrates a delivery catheter or lumen 400 that includes aworking channel 406, an optical channel 408, and a guidance or targetingfeature in the form of a protrusion 402 that extends from a distal endof an injection catheter or lumen 404. The protrusion 402 may be anydesirable shape, size, and material, and while it should be large enoughto be detectable via a visualization system, it should not be so largethat it interferes with the placement of the device within the patientand/or other functionality of the device. It is contemplated that theprotrusion 402 may be positioned in a different location relative to thedistal end of the lumen 404 than shown, and that there may be multipleprotrusions extending from a single lumen 404. These multipleprotrusions may be positioned on the same or opposite sides of the lumen404, and may be arranged in a visually detectable pattern, for example.This configuration may be particularly useful if the catheter or lumen400 is adapted for a “side fire” spray or fluid throw, although it canalso be adapted for use with other types of systems, such as “end fire”systems, for example. The protrusion is generally provided at a known orpredefined location on or along the fluid delivery catheter or lumen 400to promote positional guidance of the lumen 404 and accurate aim for theinjectate spray path.

FIG. 5 illustrates a delivery catheter or lumen 420 that has a similarconfiguration to that of the delivery catheter or lumen 400 of FIG. 4.That is, the delivery catheter or lumen 420 also includes a workingchannel 426, an optical channel 428, and a guidance or targeting featurein the form of at least one surface indicia or marker 422 on the surfaceof a distal end of an injection catheter or lumen 424. The indicia ormarker 422 may be any desirable shape or size that is detectable with acorresponding visualization system. Further, the indicia or marker 422can be the same or a different material than the injection catheter orlumen 424 on which it is located, and it may be provided on theinjection lumen 424 in any desirable application manner, such asprinting, spraying, or otherwise providing a material to the surface ofthe injection lumen 424 in a controlled manner to achieve a desiredplacement. It is further contemplated that the indicia or markers 422may alternatively or additionally be incorporated into the material ofthe injection lumen 424 themselves. The indicia or marker 422 should notbe so large that it interferes with other visualization systems of thedevice and further should not be made of a material that adverselychanges the flexibility or other physical characteristics of the device.It is also contemplated that the indicia or marker 422 may be positionedin a different location relative to the distal end of the lumen 424 thanshown, and that there may be multiple markers or indicia on the surfaceof a single lumen 424. These multiple markers or indicia may bepositioned on the same or opposite sides of the lumen 424, and may bearranged in a visually detectable pattern, for example. The indicia aregenerally provided at a known or predefined location on or along thefluid delivery catheter or lumen 420 to promote positional guidance ofthe lumen 420 and accurate aim for the injectate spray path.

Ultrasonic and/or x-ray guidance tools, systems and techniques can beused to facilitate tracking or visualization of any of the markingindicia described herein. In one embodiment, an x-ray marker will be aradiopaque material that can assist in distinguishing the marker andstructure from the surrounding environment. Ultrasonic markers can havevarious density (e.g., micro- or macroscopically), texture, or coatingattributes to distinguish the structures from the surroundingenvironment.

In another embodiment, a radiographic indicator band 442 can be disposedproximate an injection port of an injection lumen 440, as is illustratedin FIG. 6 (front view) and FIG. 7 (rear view). As shown, the indicatorband 442 is located at a known position relative to an injection port444 to allow for accurate detection of the location of the variousfeatures relative to each other. In this way, movement of the devicewill result in different visual appearances for each indicator band 442under an x-ray system to provide increasingly accurate indications ofthe orientation and location of the lumen 440.

With these exemplary guidance and tracking features embodimentsdescribed herein, it is possible to measurably reduce the size of theoverall injectate delivery system, and to provide a desirable targetedsystem to increase placement and accuracy. Further, because the guidanceand tracking features can provide a known or predefined dimensionalvariable for the system, target tissue can be sized in accordance to itsrelationship with the particular guidance and tracking feature or systemthat is used.

In order to position delivery systems of the invention in a desiredlocation relative to the patient's anatomy, the devices of the inventioncan further be provided with depth-limiting or depth-controllingfeatures at the distal end of the devices. These features can help tocontrol or limit the indentation of the distal end tip of the devicewhen positioning the injectate ports or orifices in a desired positionto promote transverse or radial injectate dispersion from the ports.Referring particularly to FIGS. 8 and 9, one exemplary embodiment of adepth-controlling system is illustrated in its open position (FIG. 8)and in its closed position (FIG. 9), although it is understood thatdifferent configurations of depth-controlling systems may be attached orotherwise provided relative to the distal end of an injection lumen. Inthis particular embodiment, a folding flange system is illustrated as acollapsible and expandable member that is hinged or otherwise able to beflexed or rotated relative to the outer surface of the injection lumen.

With continued reference to the Figures, FIG. 8 illustrates a distal endof an injection lumen 460 and two flange portions 462 that are shown asextending from the longitudinal outer surface of the lumen 460 in agenerally perpendicular direction. In one embodiment, this configurationis representative of the most extended position of the flange portions462, although it is possible that the flange portions 462 have a rangeof motion that is greater than the approximate 90-degree range of motionshown. In this position, one or more surfaces of the flange portions 462can be positioned relative to a location in a patient in order toaccurately position the lumen 460 and any of its injection orifices. Inorder to collapse the flange portions 462, they can be moved in adirection indicated by arrows 464 toward the main body of the lumen 460.

In an initial deployment position, the flange portions 462 can beexpanded manually or automatically (e.g., actively or passively) withinthe body lumen, as shown in FIG. 8. These flange portions 462 can beconstructed of a shape memory or biased material that will urge theflange portions into their expanded or open position. Alternatively, anactuation mechanism can be included in operative communication with theflange portions 462 to control expansion and contraction. Duringdeployment, the flange portions 462 can expand into abuttable contactwith the surrounding tissue walls of the body lumen to obtain an idealor predefined injection space between the injectate orifices and thetissue wall. This further provides positional anchoring of the devicewithin the body lumen, and can ensure that the injectate ports arepositioned correctly to promote transverse or radial injectatedispersion from the ports.

The flange portions 462 also provide a fixed reference for location andpositioning of the injectate ports of the injection lumen 460 adjacentthe desired target tissue. Once the injectate is applied to the targettissue, the flange portions 462 can be closed or collapsed tosubstantially follow the longitudinal length of the lumen 460 forremoval of the device from the body lumen, as shown in FIG. 9. Variousstructures, mechanisms, and techniques can be employed to facilitate theexpansion and collapsibility provided by the flange portions 462,including hinged members, shape-memory members, biasing members, pop-outmembers, inflatable members, and the like.

According to certain exemplary devices, a distal end of a shaft(injectate shaft, working shaft, or the like) can include a tissuetensioner, the tissue tensioner optionally being attached to the distalend of the shaft by a fastener that is attached to the tissue tensioner,such as part of a tissue tensioner assembly. A tissue tensioner can belocated at a distal end of a shaft, somewhat near to an injectionorifice. For example, a tissue tensioner can be located at a length-wiselocation along an injectate shaft that is the same length-wise locationas the length-wise location of an injection orifice.

The tissue tensioner can comprise an expandable surface, e.g., acontinuous expandable surface such as an inflatable balloon, or anon-continuous expandable surface such as an expandable metal (orplastic) cage or the like. The expandable surface can exhibit anexpanded state and a non-expanded state. According to exemplary methods,a tissue tensioner can be placed in a body lumen in a non-expanded stateand expanded within the lumen to the expanded state. In the expandedstate, the tissue tensioner contacts an internal surface of the lumen tohold the distal end of the shaft and an associated injection orifice inplace relative to desired tissue for injection. The tissue tensioner canoptionally produce tension or strain on the tissue in a manner that canaffect the manner in which an injected fluid stream penetrates thetissue surface and becomes distributed in the tissue upon injection. Atissue tensioner can facilitate a good result upon injection of fluidthrough luminal tissue by ensuring that the luminal tissue is fixed andincludes a desired amount of tension for receiving an injection.

Examples of tissue tensioners include inflatable balloons located at ashaft distal end near an injection orifice (e.g., at the samelength-wise location as the injection orifice), and mechanicallyextendable structures such as paddles, protrusions, levers, metal orplastic cages, metal or plastic springs or spirals, and the like, any ofwhich can include a surface that can be extended (e.g., mechanically)from a distal end of a working shaft or injectate shaft to placepressure on internal tissue, e.g., on urethral tissue within theprostatic urethra or other luminal tissue. Tissue tensioners, deviceshafts, and related mechanisms and methods are described in Applicants'copending U.S. Patent Publication. No. 2006-0129125, and U.S. PatentPublication No. 2009-0312696, the entireties of which are bothincorporated herein by reference.

When used within a lumen such as a urethra, a tissue tensioner can pushluminal tissue (e.g., urethral tissue) away from the distal end of theshaft in a manner that causes the luminal tissue and an injectionorifice to contact each other. This can be done, for example, by aballoon expanding from an opposite side of a shaft relative to aninjection orifice to place pressure on luminal tissue located oppositefrom an injection orifice and to cause the injection orifice to contactadjacent luminal tissue, optionally to produce pressure, strain, ortension on the luminal tissue opposite of the balloon. A mechanicaltensioner may be extended from a distal end of a shaft by use of anactuating mechanism such as a mechanical connection between the tissuetensioner and the proximal end of a device, such as at a working shaftproximal end. An inflatable balloon may be extended from a distal end ofa shaft by inflating the balloon with pressurized fluid such as liquid,air, other gaseous fluids, or the like.

Referring again to FIG. 1 relative to one particular embodiment, aproximal or supply end 111 of the catheter tube or injectate shaft 104extends from a distal end of the injection chamber 108. The shaft 104may be permanently attached or connected to the injection chamber 108 sothat the shaft 104 and chamber 108 are provided to the system as asingle component. Alternatively, shaft 104 may be attachable anddetachable from injection chamber 108, such as with quick connectionfittings, so that the injection chamber 108 and shaft 104 are providedto the system as separate components. Injectate shaft 104 furtherincludes a delivery or distal end 112, which is generally opposite theproximal or supply end 111.

Injectate shaft 104 may include multiple lumens, attachments, or othercomponents that may extend along all or part of the length of the tube104. Injectate shaft 104 may further comprise a number of differentconfigurations, such as an endoscope or other catheter configuration,for example. Shaft 104 can further comprise a flexible, elongatedattachment tube 114 to allow for easy positioning of the delivery ordistal end 112 within the patient.

Delivery or distal end 112 of shaft 104 can comprise a number ofdifferent configurations, which can be designed to provide treatment toa specific location in the patient's body (e.g., a rectal treatmentlocation, a gastrointestinal treatment location, a nasal treatmentlocation, a bronchial treatment location, or an esophageal treatmentlocation). The configuration of this distal end 112 is designed and/orselected to provide different types of treatment, such as can beprovided by end-fire applicators or side-fire applicators.

Another embodiment of an injection catheter device or system 210 isillustrated in FIG. 2. System 210 includes a proximal portion 212, adistal portion 214, and a shaft or body portion 216 between the proximaland distal portions. The proximal portion 212 generally includes ahandle 218 and a connection port or assembly adapted to interconnectwith a fluid source 236. The fluid source 236 is in operative andfluidic communication with the proximal portion via a conduit 234. Thefluid source 236 can include a reservoir and a pressure source capableof pressurizing and advancing fluid contained in the fluid source. Thefluid source 236 can be generally remote from the proximal portion 212and/or the distal portion 214, or provided generally proximate ordirectly attached to the device components.

A working lumen or channel 217 extends within the shaft 216 and containsa fluid delivery lumen 222. This lumen 222 is adapted to movelongitudinally along the length of the body 216 to allow its distal endto extend from the tip of the distal portion 214 as an orificeextension. The high-pressure injectate is delivered to the target tissuefrom the fluid delivery lumen 222. In particular, the injectatetraverses from the fluid source 236, into the working channel 217, andout of the fluid delivery lumen 222. Shaft 216 can include a fiber opticfeature 230, such as an endoscopic device that includes a light source220 to transmit light to the distal portion 214, for example.

In accordance with the invention, various embodiments of the fluiddelivery systems described here can be configured without means ofconnecting or attaching an optic device (e.g., endoscope) to theinjection catheter, as is illustrated with the delivery device 250 ofFIG. 3. As shown in this Figure, many of the component features of theinjection device or system 250 can be similar or identical in structureand functionality to those of the system 210 of FIG. 2 (e.g., thedelivery lumen, fluid source, and the like). However, the fluid deliverysystem 250 does not include an integrated or attached optic feature 230or a corresponding light source 220. This type of system or device canbe utilized when optics are not needed for proper device positioning,such as for systems that instead use radiographic positioning techniques(e.g., a system that uses the radiographic features described andillustrated herein relative to FIGS. 6 and 7), ultrasonic positioningtechniques, and the like. In this way, the flexibility and otherfeatures of the system 250 are not constrained by the structure of addedoptics components, and the system can therefore be designed toadvantageously include additional torque control mechanisms and/or thesystem can be designed to be smaller than a comparable system thatincludes optics. In addition, the elimination of an optics system canreduce the overall cost of the injection device or system. Inparticular, exemplary torque control mechanisms that can be incorporatedin the delivery system 250 can include one or more of a braided tube,coils, micro-machined tubes, kink-resistant tubing (KRT) features, andthe like. The torque control structures can be constructed from avariety of different materials or combination of materials, such asmetals, polymers, macroscopically and microscopically reinforcedpolymers, ceramics, and the like.

As described above, delivery systems may include lumens or cathetershaving one or more orifices for the delivery of fluid at a relativelyhigh pressure to exit a fluid delivery lumen. Due to the inherent flowcharacteristics of a fluid delivery lumen having a smooth, continuoussurface with multiple openings or orifices spaced from each other alongits length, as is illustrated in FIG. 10, the volume of high-pressurefluid exiting each of the orifices can be different, depending on howfar each of the orifices is spaced from the end of the device. Forexample, a distal end of a fluid delivery lumen 500 having a closeddistal tip has multiple orifices 502 is shown in FIG. 10. Theillustrated fluid flow depiction for such an embodiment indicates that alarger amount of injectate may exit the most distal orifice 502 ascompared to the amount of injectate that may exit the orifices 502 thatare spaced further from the closed distal tip.

In order to controllably modify these fluid volume inconsistencies,exemplary embodiments of injection lumens are illustrated in FIGS.11-13, which can include obstructions or protrusions extending into theinterior space of the lumen, along with shape and spacing configurationsfor the lumen and corresponding orifices to achieve desired orpredefined injectate fluid flow. FIG. 11 illustrates one exemplaryembodiment of such a distal end area of an injection lumen 510, which isformed or shaped to include one or more interior flow features orprotrusions 512 that controllably obstruct or modify the flow of fluidthrough the interior area of the lumen 510. These features 512 can bedefined along an interior surface or wall 514 of lumen 510 and can beadjacent to similar or identical features 512 defined in the adjacentwall of lumen 510. Alternatively, the features 512 can be provided inoffset configurations along the wall of the lumen 510. The features 512are provided to generally restrict and direct fluid flow through thelumen 510 to achieve a desired and preferred injectate output throughthe orifices 516 (e.g., flow rate, viscosity, and uniformity of suchflow characteristics). Various embodiments can include a designconfiguration for the features 512 and lumen 510 to promote increasedinjectate through one of the orifices 516 as compared to other adjacentorifices 516. For example, a central orifice can have a greater flow topromote injectate penetration along or within a central target locationof a spherical object or body lumen.

FIGS. 12 and 13 illustrate additional exemplary embodiments of injectionlumens 520 and 530, which include flow features or protrusions 522, 532,respectively. As set out above, these flow features or protrusions 522,532 can take on a variety of shapes, sizes, and spacing configurationsand can be arranged in a number of positions relative to theirrespective orifices 524, 534. For one example, flow features 522 ofinjection lumen 520 are all located on a side wall that is generallyopposite to a wall through which the orifices 524 extend. In anotherexample, flow features 532 of injection lumen 530 are all located on aside wall that also includes orifices 534 extending through it. Anycombination of these arrangements is contemplated, such as isillustrated in FIG. 11, which includes flow features 512 on both wallsthat include orifices and walls that do not include such orifices. Eachconfiguration can provide varying desired injectate flow outputs. It isunderstood that alternative lumens with various orifice and featuredesigns and relationships can be provided in accordance with theinvention to achieve the specific desired injectate output for aparticular application. It is further understood that the flowobstruction features illustrated are only intended to be exemplary andthat a particular injection lumen may include more or less protrusions,that all of the protrusions of one injection lumen may be identical ordifferently sized or shaped, and the like.

The present invention has now been described with reference to severalembodiments thereof. The entire disclosure of any patent or patentapplication identified herein is hereby incorporated by reference. Theforegoing detailed description and examples have been given for clarityof understanding only. No unnecessary limitations are to be understoodtherefrom. It will be apparent to those skilled in the art that manychanges can be made in the embodiments described without departing fromthe scope of the invention. Thus, the scope of the present inventionshould not be limited to the structures described herein, but only bythe structures described by the language of the claims and theequivalents of those structures.

The invention claimed is:
 1. A needleless fluid injection device comprising a shaft, the shaft comprising: a proximal end; a distal end; a wall extending from the proximal end to the distal end, the wall comprising a first side and an opposite second side that is unbroken from the proximal end to the distal end of the shaft; and an injection lumen defined by the wall, the injection lumen extending from the proximal end to the distal end of the shaft and comprising a central longitudinal axis, wherein the second side of the wall comprises at least one interior flow feature extending inwardly towards the central longitudinal axis of the injection lumen adjacent to the distal end of the shaft, and wherein the first side of the wall comprises at least one injection orifice adjacent to the distal end of the shaft.
 2. The injection device of claim 1, wherein the at least one interior flow feature of the unbroken second side of the wall is located adjacent to the at least one injection orifice.
 3. The injection device of claim 1, wherein the at least one interior flow feature of the unbroken second side of the wall is located generally opposite a location at which the at least one injection orifice is located.
 4. The injection device of claim 1, wherein a first interior flow feature of the at least one interior flow feature is located at a location generally opposite a second interior flow feature of the at least one interior flow feature, and wherein the first interior flow feature is located adjacent to at least one injection orifice on the first side of the wall.
 5. The injection device of claim 1, wherein the at least one interior flow feature of the unbroken second side of the wall comprises a convex surface extending in a longitudinal direction of the second wall and extending into the injection lumen.
 6. The injection device of claim 1, wherein the at least one interior flow feature of the unbroken second side of the wall comprises a first surface extending generally perpendicular to the second side of the wall and an angled surface extending from the first surface of the at least one interior flow feature.
 7. The injection device of claim 1, wherein a first interior flow feature of the at least one interior flow feature comprises a convex surface extending in a longitudinal direction of the second wall and extending into the injection lumen, and a second interior flow feature of the at least one interior flow feature comprises a first surface extending generally perpendicular to the second side of the wall and an angled surface extending from the first surface of the at least one interior flow feature.
 8. The injection device of claim 1, wherein multiple interior flow features of the at least one flow feature are spaced at equal distances from each other along a length of the second side of the wall.
 9. The injection device of claim 1, wherein multiple interior flow features of the at least one flow feature are spaced at non-equal distances from each other along a length of the second side of the wall.
 10. The injection device of claim 1, wherein the at least one interior flow feature provides for obstruction or modification of a flow of fluid through the injection lumen.
 11. The injection device of claim 1, wherein a length of a first interior flow feature of the at least one flow feature is the same as a length of a second interior flow feature of the at least one flow feature.
 12. The injection device of claim 1, wherein a length of a first interior flow feature of the at least one flow feature is different than a length of a second interior flow feature of the at least one flow feature.
 13. A needleless fluid injection device comprising a shaft, the shaft comprising: a proximal end; a distal end; a wall extending from the proximal end to the distal end, the wall comprising a first side and an opposite second side that is unbroken from the proximal end to the distal end of the shaft; and an injection lumen defined by the wall and extending from the proximal end to the distal end of the shaft and comprising a central longitudinal axis; wherein the first side of the wall comprises multiple injection orifices and at least one interior flow feature extending inwardly towards the central longitudinal axis adjacent to the distal end of the shaft.
 14. The injection device of claim 13, wherein the multiple injection orifices are spaced at equal distances from each other along a length of the first side of the wall.
 15. The injection device of claim 13, wherein the multiple injection orifices are spaced at non-equal distances from each other along a length of the first side of the wall. 